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Feasibility, Acceptability And Usability Of The InControl Web Platform - A Rando Mized Parallel-Group Pilot Study of Mixed-methods (InControl)

2026年8月18日 更新者：Anabela G Silva、Aveiro University

Feasibility, Acceptability And Usability Of The InControl Web Platform - A Mixed-methods Pilot Study

This is a randomized, parallel-group pilot study that employs mixed methods (qualitative and quantitative approaches). The purpose of this study is to assess the feasibility, usability, and acceptability of an intervention with a digital component on the InControl web platform. The intervention is based on education in pain science and exercise, with the goal of managing chronic musculoskeletal pain in older adults. The intervention will be delivered through a combination of digital and in-person components and it will be compared to the usual intervention.

It will also inform the design of a randomized controlled trial to evaluate the cost-effectiveness of InControl.

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

介入

入学 (推定)

34

段階

  • 適用できない

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • be 60 years or older;
  • have chronic musculoskeletal pain, defined as pain that persists for more than three months and is felt in the muscles, bones, joints, or tendons at least once a week;
  • know how to use a computer and/or a tablet; iv) have a score of 3 or higher on the Numerical Pain Scale for average pain intensity over the past week;
  • show no cognitive impairment, as determined by the Montreal Cognitive Assessment (MoCA) (validated and with normative data for the Portuguese population) and be available to participate in the study. The MoCA cutoff scores for the absence of cognitive impairment to be considered are adjusted for the participants' age and educational level [primary school (1-4 years), middle school (5-9 years), high school (10-12 years), and college (>12 years)], with 1.5 standard deviations: i) Ages 60-69: elementary school - 17 points, middle school - 21 points, high school and college - 22 points; ii) Ages 70-79: elementary school - 15 points, middle school - 18 points, high school - 20 points, and college - 22 points; iii) Over 80 years old: elementary school - 12 points, middle school - 22 points, high school - 17 points, and college - 19 points.

Exclusion Criteria:

  • inability to read;
  • pain associated with serious conditions (e.g., tumors, fractures);
  • any acute, unstable, or decompensated medical conditions that prevent safe physical exercise. Examples include cardiovascular diseases (recent acute myocardial infarction, unstable angina, uncontrolled cardiac arrhythmias, severe symptomatic aortic stenosis, symptomatic or unstable heart failure, acute myocarditis or pericarditis, acute aortic dissection, active endocarditis, uncontrolled hypertension), respiratory conditions (acute pulmonary embolism, pulmonary infarction, chronic obstructive pulmonary disease, uncontrolled asthma, or recent respiratory exacerbations), metabolic conditions (uncontrolled diabetes mellitus), neurological conditions (stroke, traumatic brain injury, Parkinson's disease), or acute systemic infection.
  • In addition, participants will be screened according to the American College of Sports Medicine's Preparticipation Health Screening algorithm

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：他の
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
他の：普段のお手入れ
他の：Usual Care
Usual care is defined as the treatment that the participant would normally receive such as medication, physical therapy, or any other form of treatment.
他の名前：
  • 理学療法
  • 薬
  • Psychology
  • other intervention
実験的：InControl intervention
他の：InControl intervention
The InControl intervention lasts 8 weeks and combines educational content on pain science and exercise on a digital platform. InControl is the result of a co-creation process between healthcare professionals and older adults with lived experience of chronic musculoskeletal pain.
他の名前：
  • エクササイズ
  • Digital intervention
  • 痛みの科学教育
  • Functional objective
  • In-person

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Rates
時間枠：From enrollment to the end of treatment at 8 weeks
inclusion, refusal, exclusion, dropout and retetion
From enrollment to the end of treatment at 8 weeks
System Usability Scale
時間枠：At the end of 8 weeks of intervention
Usability evatuated wiht the portuguese version of SUS The score ranges from 0 to 100. Higher scores are interpreted as indicating better usability.
At the end of 8 weeks of intervention
Estructured questionnaire to assess aceptability
時間枠：At the end of 8 weeks of intervention
Estructured questionnaire Ten items, with scores ranging from 1 - totally disagree to 5 - totally agree
At the end of 8 weeks of intervention
Semi-structured interview
時間枠：At the end of 8 weeks of intervention
Semi-structured interview to explore participants' perceptions about programme acceptability
At the end of 8 weeks of intervention

二次結果の測定

結果測定
メジャーの説明
時間枠
Sex
時間枠：Baseline
Please indicate the appropriate option: male, female, prefer not to say, other (please specify)
Baseline
Age
時間枠：Baseline
number of years
Baseline
Marital status
時間枠：Baseline
Select your marital status: Single, Married, In a civil partnership, Divorced Widowed
Baseline
Level of education
時間枠：Baseline
Please select your level of education: Can read and write; 4th year of schooling; 6th year of schooling; 9th year of schooling; 12th year of schooling; Bachelor's degree; Other (please specify)
Baseline
Employment status
時間枠：Baseline
Please select: Full-time employee, Part-time employee, Domestic worker, Unemployed, Retired, Temporarily unfit for work
Baseline
Weight
時間枠：Baseline
weight in kilograms
Baseline
Height
時間枠：Baseline
height, in metres
Baseline
Falls
時間枠：Baseline
number of falls in the last year
Baseline
Number of medicines
時間枠：Baseline
number of regular medicines
Baseline
Comorbidities
時間枠：Baseline
Please select: No medical conditions, High blood pressure, Diabetes, Osteoarthritis (please specify the affected area), Cardiovascular conditions, Respiratory conditions, Neurological conditions, Cancer, Arthritis, Osteoporosis, Vision problems, Hearing problems, Other (please specify)
Baseline
EQ-5D-5L
時間枠：At baseline and at the end of the 8-week intervention
The EQ-5D-5L score ranges from 1 to 5 for each domain
At baseline and at the end of the 8-week intervention
EQ-VAS
時間枠：At baseline and at the end of the 8-week intervention
The score of EQ-VAS ranges from 0 to 100. Higher scores are interpreted as indicating a better perception of health quality
At baseline and at the end of the 8-week intervention
Montreal Cognitive Assessment
時間枠：At baseline and at the end of the 8-week intervention
MoCA scores range from 0 to 30. Higher scores indicate better cognitive performance
At baseline and at the end of the 8-week intervention
Brief Pain Inventory
時間枠：At baseline and at the end of the 8-week intervention
On the pain severity subscale, scores range from 0 to 40 points. On the pain-related interference subscale, scores range from 0 to 70 points. Higher scores indicate greater severity or pain-related interference, respectively
At baseline and at the end of the 8-week intervention
Location and number of painful sites
時間枠：At baseline and at the end of the 8-week intervention
Bodychart
At baseline and at the end of the 8-week intervention
PainDETECT Questionnaire
時間枠：At baseline and at the end of 8-week intervention
The score ranges from -1 to 38 points
At baseline and at the end of 8-week intervention
Hand grip strength
時間枠：At baseline and at the end of 8-week intervention
Kg
At baseline and at the end of 8-week intervention
Gait speed test
時間枠：At baseline and at the end of 8-week intervention
metres per second
At baseline and at the end of 8-week intervention
5-sit-to-stand test
時間枠：At baseline and at the end of 8-week intervention
time in seconds
At baseline and at the end of 8-week intervention
Rapid Assessment of Physical Activity
時間枠：At baseline and at the end of 8-week intervention
Depending on physical activity, there are five levels of physical activity: sedentary - item 1, ii) slightly active - item 2, iii) regularly slightly active (light activity) - item 3, iv) regularly slightly active - items 4 and 5, and v) active - items 6 and 7
At baseline and at the end of 8-week intervention
Pain Catastrophizing Scale
時間枠：At baseline and at the end of 8-week intervention
The minimum score is 0 and the maximum is 52. Higher scores are associated with higher levels of catastrophic thinking
At baseline and at the end of 8-week intervention
Tampa Scale of Kinesiophobia
時間枠：At baseline and at the end of 8-week intervention
Scores range from 13 to 52 points. Higher scores are associated with greater fear of movement
At baseline and at the end of 8-week intervention
Geriatric Depression Scale
時間枠：At baseline and at the end of 8-week intervention
Scores range from 0 to 15. Higher scores indicate more depressive symptoms
At baseline and at the end of 8-week intervention
Strength, Assistance with walking, Rise from a chair, Climb stairs and Falls
時間枠：At baseline and at the end of 8-week intervention
SARC-F. Scores range from 0 to 10. Total scores of 4 or above are suggestive of sarcopenia
At baseline and at the end of 8-week intervention
Patient Global Impression of Change
時間枠：At the end of 8-week intervention
Scores range from 1 to 7. Higher scores indicate a greater overall perception of improvement
At the end of 8-week intervention

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Aveiro University

捜査官

  • 主任研究者：Anabela G. Silva, PhD、University of Aveiro

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2026年12月1日

研究の完了 (推定)

2026年12月1日

試験登録日

最初に提出

2026年7月28日

QC基準を満たした最初の提出物

2026年8月18日

最初の投稿 (実際)

2026年8月19日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月19日

QC基準を満たした最後の更新が送信されました

2026年8月18日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • Currently in submission

個々の参加者データ (IPD) の計画

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いいえ

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